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| Name | Class |
|---|---|
| Children's Hospital Colorado | OTHER |
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This study will test the hypothesis that metabolic bariatric surgery will be more effective at providing durable glycemic control and reduce co-morbidities than intensive medical therapy in youth with type 2 diabetes.
Youth-onset type 2 diabetes (T2D) leads to early dependence on exogenous insulin and progression of T2D co-morbidities, including dyslipidemia, hypertension, non-alcoholic fatty liver disease and diabetic kidney disease. The pathophysiology of T2D in youth differs considerably from adults and current treatment approaches are in-adequate for youth. Thus, exploration of innovative approaches to reduce co-morbidities is critical. Metabolic bariatric surgery (MBS) significantly improves multiple outcomes in adults with T2D. Initial small, uncontrolled studies of Roux-en-Y gastric bypass also suggest beneficial effects in youth with T2D, but definitive studies and understanding of mechanisms in youth-onset T2D are lacking, especially with the now more common form of MBS, vertical sleeve gastrectomy (VSG).
We will test the hypothesis that VSG will be more effective in reducing glycemia and comorbidities than the best currently available medical treatment: advanced medical therapy (AMT), via pancreatic, enterohepatic and/or metabolic changes. To test this hypothesis, 90 adolescents with T2D will be studied to compare the effects of VSG vs. AMT on glycemic control and T2D-associated comorbidities, as well as underlying mechanisms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes | Active Comparator | Youth with type 2 diabetes undergoing bariatric surgery, n=45 |
|
| Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes | Active Comparator | Youth with type 2 diabetes receiving medical management, n=45 |
|
| Bariatric Surgery in Youth with Obesity | Active Comparator | Youth with no obesity undergoing bariatric surgery, n=10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced Medical Therapy and Bariatric Surgery | Procedure | Vertical Sleeve Gastrectomy and Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | Hemoglobin A1c of <6.5% | At one year |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | Hemoglobin A1c <6.5% at 2 years | At two years |
| Glycemic Variability | Time In Range by Continuous Glucose Monitoring |
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Inclusion Criteria for the medical or surgical type 2 diabetes groups
Exclusion Criteria for the medical or surgical type 2 diabetes groups Known type 1 diabetes, maturity onset diabetes of the young (MODY), or secondary diabetes
Exclusion Criteria for the obese control group
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| Name | Affiliation | Role |
|---|---|---|
| Amy S Shah, MD MS | Cincinnati Childrens Hospital Medical Center | Principal Investigator |
| Kristen J Nadeau, MD MS | Children's Hospital Colorado | Principal Investigator |
| Michael A Helmrath, MD MS | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Thomas H Inge, MD PhD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| Lurie Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34389568 | Derived | Shah AS, Helmrath MA, Inge TH, Xanthakos SA, Kelsey MM, Jenkins T, Trout AT, Browne L, Nadeau KJ. Study protocol: a prospective controlled clinical trial to assess surgical or medical treatment for paediatric type 2 diabetes (ST2OMP). BMJ Open. 2021 Aug 13;11(8):e047766. doi: 10.1136/bmjopen-2020-047766. |
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The PI's will also report a of summary results information (including adverse events) after completion of the study. All data from the study including any negative findings will be published in peer reviewed manuscripts.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Open label prospective clinical trial. Primary comparison is medical (n=45) vs surgical (n=45) groups. Patients with obesity and no diabetes (n=10) are a comparator group.
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| Advanced Medical Therapy | Drug | Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes |
|
| Bariatric Surgery | Procedure | Vertical Sleeve Gastrectomy for youth without type 2 diabetes |
|
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| At one year |
| Beta Cell Function | Oral disposition index= Insulin secretion [insulinogenic index] * insulin sensitivity [1/fasting insulin] | at 1 and 2 years |
| Alpha cell function | Glucagon area under the curve from mixed meal tolerance testing | at 1 and 2 years |
| Incretin Response | GLP-1 area under the curve from mixed meal tolerance testing | at 1 and 2 years |
| Fatty Liver Disease | Hepatic Fat (<5% )by Magnetic Resonance imaging | at 1 and 2 years |
| Dyslipidemia | LDL <130mg/dL | at 1 and 2 years |
| Hypertension | Blood pressure <130/80 mmHg | at 1 and 2 years |
| Diabetic Kidney Disease | Urinary albumin excretion <30μg/mg | At 1 and 2 years |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Cincinnati Childrens | Cincinnati | Ohio | 45229 | United States |
| D004700 | Endocrine System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |